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510(k) K901377

BARTON-MAYO TRACHEOSTOMA BUTTON by Medical Innovations International, Inc. — Product Code KAC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 14, 1990
Date Received: March 22, 1990
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tube, Laryngectomy
Device Class: Class I
Regulation Number: 874.4420
Review Panel: EN
Submission Type